Caballero-Villarraso Javier, Villegas-Portero Román, Rodríguez-Cantalejo Fernando
Servicio de Análisis Clínicos, Hospital Universitario Reina Sofía, Córdoba, España.
Aten Primaria. 2011 Mar;43(3):148-56. doi: 10.1016/j.aprim.2010.03.017. Epub 2010 Oct 30.
To compare portable coagulometer devices and conventional coagulometers. The clinical validity will be estimated via anticoagulation control (maintenance of therapeutic range), patient satisfaction, thrombotic or haemorrhagic events and mortality. Analytical validity will be studied in quality control terms.
Systematic review.
MEDLINE and EMBASE databases, CRD, Cochrane, EMEA, FDA, EuroScan and the ClinicalTrials.gov.
Inclusion criteria were studied in patients on anticoagulation therapy who used portable coagulometer devices. In an additional undertaking, the comparison with lab references was looked for, in order to evaluate the effectiveness. The quality of selected studies was assessed according to CASPe check-list. As meta-analysis was not possible, a qualitative synthesis was made.
Four evaluation reports and 7 systematic reviews were selected (two of them with meta-analysis). After these, 22 original articles were included for this review and they had high or very high score for CASPe check-list (≥7/10). Almost all of the studies found very high correlations between portable coagulometer devices and conventional coagulometers (r>90), and clinical advantages such as lower incidence of thromboembolism events. Three systematic reviews showed a lower mortality index.
The analytical-validity related articles show that portable coagulometers have an equivalent effectiveness to conventional coagulometers. Studies that include patient-reported outcomes show that self-monitoring patients, by means of portable coagulometers, have better analytical measurement results and fewer rates of thromboembolic events. Survival was analysed in very few studies; nevertheless, all of these show lower mortality. Similarly, the minority of selected articles includes economic evaluations, although they suggest a better cost-effectiveness of portable coagulometers compared to the conventional mode.
比较便携式凝血仪与传统凝血仪。将通过抗凝控制（维持治疗范围）、患者满意度、血栓形成或出血事件及死亡率来评估临床有效性。将从质量控制方面研究分析有效性。
系统评价。
MEDLINE和EMBASE数据库、CRD、Cochrane、欧洲药品管理局（EMEA）、美国食品药品监督管理局（FDA）、欧洲扫描数据库（EuroScan）及临床试验.gov。
纳入标准为接受抗凝治疗且使用便携式凝血仪的患者。另外，为评估有效性，寻找与实验室参考值的比较。根据CASPe清单评估所选研究的质量。由于无法进行荟萃分析，因此进行了定性综合分析。
选择了4份评估报告和7篇系统评价（其中2篇有荟萃分析）。在此之后，本综述纳入了22篇原始文章，它们在CASPe清单上的得分很高或非常高（≥7/10）。几乎所有研究都发现便携式凝血仪与传统凝血仪之间具有非常高的相关性（r>90），以及诸如血栓栓塞事件发生率较低等临床优势。3篇系统评价显示死亡率指数较低。
与分析有效性相关的文章表明，便携式凝血仪与传统凝血仪具有同等有效性。纳入患者报告结局的研究表明，通过便携式凝血仪进行自我监测的患者具有更好的分析测量结果和更低的血栓栓塞事件发生率。很少有研究分析生存率；然而，所有这些研究均显示死亡率较低。同样，所选文章中少数包括经济评估，尽管它们表明与传统模式相比，便携式凝血仪具有更好的成本效益。
